NCT03310515

Incidence of Human Immunodeficiency Virus-1 (HIV-1) Infection in HIV-1 Uninfected High Risk Men Who Have Sex With Men

A Cohort Study to Determine the Incidence of HIV-1 Infection in HIV-1 Uninfected High Risk Participants Who Are Male Sex at Birth and Have Sex With Men

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 578 (actual)
• Sponsor: ViiV Healthcare · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

Studies to assess the effectiveness of interventions to prevent HIV infection depend upon robust estimates of Baseline HIV incidence rates. The changing landscape of high-risk populations, as well as the evolution of biomedical pre-exposure prophylaxis (PrEP) interventions, requires a contemporary evaluation of HIV incidence as well as demographic, behavioral and other subject factors which may impact HIV incidence. This is a prospective cohort study to measure HIV-1 seroincidence in a study population of HIV-1 uninfected Chinese men who have sex with men (MSM) and transgender women (TGW) who are at high-risk of HIV infection. Approximately 550 subjects who are male sex at birth and have sex with men shall enter the study, which will allow for a 10% drop out rate to maintain 500 subjects at the conclusion of the cohort. This is a single arm cohort study to determine HIV-1 seroincidence rates in high risk MSM and TGW when combined with a comprehensive prevention package including HIV and safe sex counseling, provision of condoms and water-based lubricant, and sexually transmitted infection (STI) screening and referral for treatment. It will be determined what proportion of high-risk MSM and TGW who are given a comprehensive HIV-1 prevention package will acquire HIV-1 infection.

Conditions

• Infection, Human Immunodeficiency Virus
• HIV Infections

Interventions

Type	Name	Description
BEHAVIORAL	Risk reduction counseling	Subjects will receive comprehensive prevention package including HIV and safe sex counseling, provision of condoms and water-based lubricant, and STI screening and referral for treatment.
OTHER	Social harm interview	Information regarding social harms (loss of privacy, stigmatization, interference with gainful employment, and coercion) will be solicited during bi-monthly study visits after enrollment in the study and will be recorded. Subjects who report social harms will be referred to speak with a social worker and/or a study counselor.
OTHER	Computer-Assisted Self Interviewing technique	Demographic, behavioral, and psychosocial factors associated with HIV acquisition will be assessed by CASI.

Timeline

• Start date: 2017-08-31
• Primary completion: 2018-12-31
• Completion: 2018-12-31
• First posted: 2017-10-16
• Last updated: 2020-03-12

Locations

9 sites across 1 country: China